Prequalification of Active Pharmaceutical Ingredients - List of
WHO List of Prequalified Active Pharmaceutical
This list contains sources of
active pharmaceutical ingredients (APIs) that have been assessed
as part of the WHO Prequalification Programme and found to
be acceptable, in principle, for use in finished
pharmaceutical products procured by UN agencies.
Prequalification of APIs generally involves evaluation of data relating to
their quality as well as inspection of the relevant
manufacturing site, as described elsewhere on this web site.
The APIs listed are those for which - at the time of assessment -
submitted data and information submitted
were found to meet WHO norms and standards and for which - at the time of inspection - the relevant
manufacturing sites were found to comply with Good
Some of the APIs have
been listed on the basis of assessment and inspection carried out by
regulatory authorities who are willing to share
information with WHO.